Columbia University Irving Medical Center
Clinical Research Coordinator I - Cardiology
Columbia University Irving Medical Center, New York, New York, us, 10261
Clinical Research Coordinator I - Cardiology
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Clinical Research Coordinator I - Cardiology
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Columbia University Irving Medical Center Salary and Position Details
Salary Range: $66,300 - $72,500 Annually Grade: 104 Job Type: Officer of Administration Regular/Temporary: Regular Hours Per Week: 35 The salary of the finalist selected for this role will be set based on a variety of factors, including but not limited to departmental budgets, qualifications, experience, education, licenses, specialty, and training. The above hiring range represents the University's good faith and reasonable estimate of the range of possible compensation at the time of posting. Position Summary
The Clinical Research Coordinator I is an intermediate level position that provides independent study coordination for simple and moderately complex clinical research studies such as registries, retrospective data reviews, studies in long‑term follow‑up, and other non‑interventional studies, and under supervision provides study coordination for moderate to high complexity clinical trials such as EFS and pivotal IDE/IND studies. Responsibilities include consent, screening for eligibility, identification of adverse events under minimal supervision, completing subject follow‑ups, source documentation, device accountability, and preparing for monitoring visits independently. The CRC I should be capable of independently performing tasks, making decisions, and consistently delivering accurate and high‑quality work. Responsibilities
Clinical Coordination
May create a recruitment plan that addresses the needs of the study population. Demonstrates ability to screen participants for study eligibility & enroll with accuracy in various databases. Demonstrates ability to find and utilize information from EMR and databases/CTMS/EDC. Understands protocol elements/requirements and executes study procedures. Ensures study compliance based on protocol structure. Uses proper documentation techniques as outlined in the ICH‑GCP guidelines. May complete P‑card reimbursement to patients. Processes subject visit billing and tracks invoiceable items. Schedules, assists with preparation, and attends study initiation meetings, audits, and monitor visits. Obtains informed consent from subject. Conducts all startup, active implementation, and closeout activities. Assesses studies for execution and troubleshoots potential implementation issues. Anticipates and mitigates potential for protocol non‑compliance. Triages subject concerns and issues appropriately. Performs moderately complex study procedures with accuracy. Data Coordination
Enters data to complete forms (CRFs) on paper, databases, or EDCs. Resolves moderately complex queries. Utilizes information from the EMR and study databases. Completes moderately complex data collection during study visits. Documents data in accordance with ALCOA‑C principles. Administers surveys and questionnaires. Performs concomitant medications abstraction. Builds patient research study charts. Assists with collection of external medical records, CLIAs, CAPs, and radiology CDs as assigned. Contributes to the development of processes and tools for data capture. Creates and manages databases. Regulatory Coordination
Maintains essential regulatory documents as outlined in the ICH‑GCP guidelines. Assists Regulatory manager in submission and management of IRB applications. Identifies Adverse Events (AEs), Serious Adverse Events (SAEs), and reports appropriately. Manages increasing levels of protocol complexity or volume efficiently. Ensures subject safety documentation and reporting. Escalates situations promptly and demonstrates actions to minimize risks. Applies key regulatory requirements to control investigational product development. Administrative Responsibilities
Provides other administrative support for study activity including scanning and filing. Communicates with study participants via mail or email. Schedules subjects for research visits and follow‑up appointments. Checks study calendar for completion of procedures. Manages study supply inventory. Tracks recruitment and retention of participants. Participates in regular study meetings. Provides guidance on Federal and University policy and guidelines. Acts as liaison between investigators, research teams, sponsors, and other departments. Training
Gains appropriate training & knowledge of EMR, CTMS, EDC, and databases. Attends all assigned training, including CITI, GCP, HIPAA. Understands disease process per program. Participates in training for maintaining certification as a Clinical Research Professional. Provides training and mentorship for CRC staff. Competency
Functional Knowledge: Strong understanding of research subject matter. Problem Solving: Analyzes moderately complex situations to implement solutions. Decision Making/Autonomy: Performs projects with limited supervision, collaborating with PI and Clinical Research Manager. Communication Skills: Summarizes and explains research information effectively. Other Responsibilities
May include additional tasks based on unit needs, with potential emphasis on clinical, data, regulatory, or other specific areas. Minimum Qualifications
Bachelor's degree or equivalent in education and/or experience, plus 3 years of experience. Mastered competency of the specific responsibilities and duties from the CRC. Technical competency in areas such as regulatory requirements, data management, and study documentation. Experience in managing study‑specific procedures, including patient eligibility screening, informed consent, and adverse event reporting. Other Requirements
Participation in the medical surveillance program: Contact with patients and/or human research subjects. Successful completion of applicable compliance and systems training requirements. Equal Opportunity Employer / Disability / Veteran
Columbia University is committed to the hiring of qualified local residents.
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Join to apply for the
Clinical Research Coordinator I - Cardiology
role at
Columbia University Irving Medical Center Salary and Position Details
Salary Range: $66,300 - $72,500 Annually Grade: 104 Job Type: Officer of Administration Regular/Temporary: Regular Hours Per Week: 35 The salary of the finalist selected for this role will be set based on a variety of factors, including but not limited to departmental budgets, qualifications, experience, education, licenses, specialty, and training. The above hiring range represents the University's good faith and reasonable estimate of the range of possible compensation at the time of posting. Position Summary
The Clinical Research Coordinator I is an intermediate level position that provides independent study coordination for simple and moderately complex clinical research studies such as registries, retrospective data reviews, studies in long‑term follow‑up, and other non‑interventional studies, and under supervision provides study coordination for moderate to high complexity clinical trials such as EFS and pivotal IDE/IND studies. Responsibilities include consent, screening for eligibility, identification of adverse events under minimal supervision, completing subject follow‑ups, source documentation, device accountability, and preparing for monitoring visits independently. The CRC I should be capable of independently performing tasks, making decisions, and consistently delivering accurate and high‑quality work. Responsibilities
Clinical Coordination
May create a recruitment plan that addresses the needs of the study population. Demonstrates ability to screen participants for study eligibility & enroll with accuracy in various databases. Demonstrates ability to find and utilize information from EMR and databases/CTMS/EDC. Understands protocol elements/requirements and executes study procedures. Ensures study compliance based on protocol structure. Uses proper documentation techniques as outlined in the ICH‑GCP guidelines. May complete P‑card reimbursement to patients. Processes subject visit billing and tracks invoiceable items. Schedules, assists with preparation, and attends study initiation meetings, audits, and monitor visits. Obtains informed consent from subject. Conducts all startup, active implementation, and closeout activities. Assesses studies for execution and troubleshoots potential implementation issues. Anticipates and mitigates potential for protocol non‑compliance. Triages subject concerns and issues appropriately. Performs moderately complex study procedures with accuracy. Data Coordination
Enters data to complete forms (CRFs) on paper, databases, or EDCs. Resolves moderately complex queries. Utilizes information from the EMR and study databases. Completes moderately complex data collection during study visits. Documents data in accordance with ALCOA‑C principles. Administers surveys and questionnaires. Performs concomitant medications abstraction. Builds patient research study charts. Assists with collection of external medical records, CLIAs, CAPs, and radiology CDs as assigned. Contributes to the development of processes and tools for data capture. Creates and manages databases. Regulatory Coordination
Maintains essential regulatory documents as outlined in the ICH‑GCP guidelines. Assists Regulatory manager in submission and management of IRB applications. Identifies Adverse Events (AEs), Serious Adverse Events (SAEs), and reports appropriately. Manages increasing levels of protocol complexity or volume efficiently. Ensures subject safety documentation and reporting. Escalates situations promptly and demonstrates actions to minimize risks. Applies key regulatory requirements to control investigational product development. Administrative Responsibilities
Provides other administrative support for study activity including scanning and filing. Communicates with study participants via mail or email. Schedules subjects for research visits and follow‑up appointments. Checks study calendar for completion of procedures. Manages study supply inventory. Tracks recruitment and retention of participants. Participates in regular study meetings. Provides guidance on Federal and University policy and guidelines. Acts as liaison between investigators, research teams, sponsors, and other departments. Training
Gains appropriate training & knowledge of EMR, CTMS, EDC, and databases. Attends all assigned training, including CITI, GCP, HIPAA. Understands disease process per program. Participates in training for maintaining certification as a Clinical Research Professional. Provides training and mentorship for CRC staff. Competency
Functional Knowledge: Strong understanding of research subject matter. Problem Solving: Analyzes moderately complex situations to implement solutions. Decision Making/Autonomy: Performs projects with limited supervision, collaborating with PI and Clinical Research Manager. Communication Skills: Summarizes and explains research information effectively. Other Responsibilities
May include additional tasks based on unit needs, with potential emphasis on clinical, data, regulatory, or other specific areas. Minimum Qualifications
Bachelor's degree or equivalent in education and/or experience, plus 3 years of experience. Mastered competency of the specific responsibilities and duties from the CRC. Technical competency in areas such as regulatory requirements, data management, and study documentation. Experience in managing study‑specific procedures, including patient eligibility screening, informed consent, and adverse event reporting. Other Requirements
Participation in the medical surveillance program: Contact with patients and/or human research subjects. Successful completion of applicable compliance and systems training requirements. Equal Opportunity Employer / Disability / Veteran
Columbia University is committed to the hiring of qualified local residents.
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